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Actual Job Title = Biostats Specialist
Typical Daily Work Hours = 830am to 5pm (some flexibility in start/end times, 40 hrs/wk)
Weekend & OT work not required, but would like the candidates to be open to it, if needed.
100% onsite work.
Responsibilities will include, but are not limited to:
• Work under the direction of Medical Affairs Statistics Disease Lead
• Provide statistical input for design, sample size, and protocol for Medical Affairs studies
• Provide / review of statistical analysis plan including Tables/Listings/Figures shells, Analysis Dataset Specifications and all deliverables for Medical Affairs studies provided by the CRO
• Manage outside CROs and Statistics/Programming counterparts at CROs
• Act as primary CRO contact, when necessary, to ensure that Client standards are implemented in all studies
• Manage project priorities and timelines
• Conduct/supervise programming validation of statistical outputs related to efficacy and safety for outsourced studies
• Participate in and lead study team meetings when appropriate, e.g., discussion of statistical topics
• Routinely interface with cross-functional team members in different departments (e.g., clinical, medical affairs, marketing, data management, medical writing, programming, regulatory, health economics, clinical trials sharing etc.) and provide statistical support as needed for a variety of functional groups
• Participate in reviews of Clinical Study Reports (CSR) and contribute to successful completion of CSRs
• ***(BIG PLUS if candidate has this experience) Provide statistical support for publications, abstracts and presentations at Medical Congresses and other requests not covered in the Clinical Study Reports. Conduct exploratory and ad hoc analyses as requested by stakeholders. This includes staying up-to-date and implementing current advanced statistical methods in literature, data mining, meta-analysis and data driven analyses
• ***(BIG PLUS if candidate has this experience) Interact with authors, referees, and in-house reviewers in the preparation of publications
• Coach and advise Statistical / Clinical programmers to identify problems and solutions
• MS / PhD degree in Statistics or equivalent in a relevant scientific discipline with a minimum of three years experience
• Advanced knowledge of statistical methodology and clinical trials is desired
• Experience with Oncology therapeutic area is desire.
• Experience working with Statistical Programmers and Clinical teams is desired
• Good communication skills; ability to work in a team environment comprising of data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers
• Knowledge of FDA/ICH guidelines and industry standard practices regarding programming
• Medical or mathematics/computer science background a plus
• Computer skills: Detailed knowledge of Statistical Programming such as in SAS, R and other statistical software, proficiency with SAS data sets, knowledge of MS Office program suite
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